FDA Authorizes Emergency Use of Test for H1N1, or Swine Flu

10/26/2009 - News

FDA Authorizes Emergency Use of Test for H1N1, or Swine Flu

By: June Chen, MD

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Last Friday, the U.S. Food and Drug Administration announced that it has issued an Emergency Use Authorization (EUA) for another test that can be used to diagnose the 2009 H1N1 influenza, or swine flu, virus.

EUA authority allows the FDA to authorize the use of unapproved medical products or unapproved uses of approved medical products following a determination and declaration of emergency, such as the H1N1 pandemic.
 
The EUA has been issued for the Focus Diagnostics Influenza H1N1 (2009) Real-Time Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) test, the third diagnostic test authorized under an EUA since the 2009 H1N1 influenza virus was characterized as a pandemic on April 26, 2009. This RT-PCR test is a complex laboratory test which is intended for use in detecting the 2009 H1N1 influenza virus in individuals with symptoms of respiratory infection. It works by amplifying viral genetic material obtained from swabs of the nose or throat or from nasal discharges. Although the test can identify the presence of the virus, it cannot determine the stage of infection.
 
The EUA for this H1N1 test will remain in effect until either the declaration of emergency is terminated or when the FDA revokes the authorization.
 
 

Source:

U.S. Food and Drug Administration Press Announcements. Accessed July 24, 2009.

 

Created on: 07/27/2009
Reviewed on: 10/26/2009

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